MAUDE Adverse Event Report: BELMONT MEDICAL TECHNOLOGIES CRITICOOL; THERMAL REGULATING SYSTEM

Catalog Number 100-00004

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017); Device-Device Incompatibility (2919)

Patient Problem Superficial (First Degree) Burn (2685)

Event Type  malfunction  

Manufacturer Narrative

The internal complaint file #(b)(4) has been logged for this incident for traceability.The device involved in this incident was not returned to belmont for investigation.It was determined that the criticool system was used on a patient with a gentherm maxitherm lite wrap despite the user manual containing the following "the belmont medical technologies wrap is proprietary to belmont medical technologies and this is the only wrap authorized to be used with the criticool® system.Use of any other wrap with the system may harm the patient." there was no report that the reported burn required medical intervention to prevent a life-threatening condition or permanent impairment to the body.It was determined this incident was due to user error as a non-belmont wrap was utilized.No other incidents of this kind have previously been reported to belmont.The user was made aware of the existing statement within the manual "the belmont medical technologies wrap is proprietary to belmont medical technologies and this is the only wrap authorized to be used with the criticool® system.Use of any other wrap with the system may harm the patient".And that only belmont wraps should be used with the criticool system.In order to ensure that the belmont's device is used as intended, belmont has contacted the user facility to arrange additional training for clinical staff and demonstrate the correct use of criticool system per our specifications.A follow-up report will be submitted once the training is complete and additional information becomes available.

Event Description

It was reported to belmont that a criticool system used on a patient with a gentherm maxitherm litewrap (instead of the required curewrap) and that the patient suffered skin burns.

• Brand Name: CRITICOOL
• Type of Device: THERMAL REGULATING SYSTEM
• Manufacturer (Section D): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer (Section G): BELMONT MEDICAL TECHNOLOGIES; 780 boston road; billerica MA 01821
• Manufacturer Contact: urja jani ; 780 boston road; billerica, MA 01821
• MDR Report Key: 18587064
• MDR Text Key: 333843333
• Report Number: 1219702-2024-00005
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 07290012127038
• UDI-Public: 7290012127038
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K083662
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 100-00004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1